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Watson Pharama
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Quality Specialist II

Quality Specialist II

Watson Pharama

2 - 8 years

4 - 10 Lacs

bengaluru

Posted:-1 days ago| Platform:

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Skills Required

quality control iso quality audit production regulatory documentation final quality gmp ich assurance quality analysis qc quality management product quality sop quality assurance qms manufacturing regulatory affairs production planning

Work Mode

Work from Office

Job Type

Full Time

Job Description

Ensures that the review of CMC documentation is completed in timely & compliant manner as per Teva CORP standards and related Guidance s.

Review of Method Development/Validation Protocols & Reports, Stability Protocols & Reports received from various Teva contracting sites, R&D units, Method Development & Stability Testing Centres.

Review of Instrument/Equipment Qualification records.

Review of BMR.

Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.

Compilation of high quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and system

Liaising with third party contract manufacturers and QA/QC/Technical support personnel located globally for data collection and arranging responses.

Recommend actions and professionally communicate to sites/ Quality units for continuous improvement in quality of products
Receives guidance from Supervisor, Group Leader, Manager Global Quality Services, Associate Director Global Quality GBS, other Managers in Quality Strategy & Shared Services, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites

How you ll spend your day

Review of CMC Documentation

Review of Method Development / Validation protocols & reports.

Review of Stability Study protocol, reports & grids.

Review of Instrument / Equipment Qualification records.

Review of Batch Manufacturing Records.

Liaising with contracting Teva units and QA/QC personnels located globally for arranging required documents and query responses.

Escalation of issues to Supervisor, Group Leader, Manager Global Quality GBS.

Contemporaneous updation of SharePoint data base

Data requesting and Compilation of PQR s

Compilation of high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and systems

Liaising with third party contract manufacturers and QA personnel located globally for data collection required for compilation of APRs/ PQRs.

Follow up with the CMO s for the receipt of data within time.

Check quotation received from CMO and initiate PR/PO for QP s approval.

Once the data is received responsible for filling the PQR receipt checklist and scheduling the PQR in SharePoint.

Escalation of PQR issues to Supervisor, Group Leader, Manager PQR Centre.

Contemporaneous updation of SharePoint data base

Quality Management Systems

Initiate the process of change controls and deviations

Preparation of local SOP s and its related documents.

Participate in self-inspection process

Performance Management

Participate in continuous process improvement projects to improve efficiency of the unit

Training

Prepare the Training Materials for GMP training and on the job training.

Imparts training on procedures as needed.

Miscellaneous Support

Any other tasks assigned by the management for smooth functioning of the team

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